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Weight Management: a team approach

Weight Management: a team approach. Crystal Whitman, PharmD , BCACP Aleda E. Lutz VA Medical Center Saginaw, MI. Objectives. 1. Evaluate the current guidelines for the management of overweight and obesity in adults.

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Weight Management: a team approach

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  1. Weight Management: a team approach Crystal Whitman, PharmD, BCACP Aleda E. Lutz VA Medical Center Saginaw, MI

  2. Objectives 1. Evaluate the current guidelines for the management of overweight and obesity in adults. 2. Identify the components of a high-intensity, comprehensive-lifestyle intervention program. 3. Review treatment options that may aid patients in their weight loss goals.

  3. Case 1 • MK is a 32 y.o. hispanicfemale with body mass index (BMI) of 32. She has a diagnosis of hypertension (HTN) and hypothyroidism. She discusses her and her spouse’s desire to become pregnant within the next year and her frustrations with her current weight. She reports ‘trying really hard at home’ without success. What is your recommendation? A. phenteramine/topiramate(Qsymia) B. diethylpropion C. acomprehensive lifestyle intervention program D. bariatric surgery

  4. What do we know?

  5. Obesity Trends* Among U.S. AdultsBRFSS,1990, 2000, 2010 • (*BMI 30, or about 30 lbs. overweight for 5’4” person) www.cdc.gov/obesity/downloads/obesity_trends_2010.ppt BRFSS: Behavioral Risk Factor Source Surveillance System No Data <10% 10%–14% 15%–19% 20%–24% 25%–29% ≥30%

  6. Statistics • More than one-third of U.S. adults (35.7%) are obese • Overweight (BMI>25)= 69% • The estimated annual medical cost of obesity in the U.S. was $147 billion in 2008 U.S. dollars • $99.2 billion in 1995 • The medical costs for people who are obese were $1,429 higher than those of normal weight http://www.cdc.gov/obesity/data/adult.html NIH, NHLBI. Clinical Guidelines on the identification, evaluation, and treatment of overweight and obesity in Adults. The evidence report. NIH Publication No. 98-4083, 1998.

  7. Who responded? • National Heart, Lung, Blood Institute (NHLBI) in cooperation with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) • Identification, Evaluation, and Treatment of Overweight and Obesity In Adults (1998) • Examined the evidence of benefits • Assessment/classification: BMI, waist circumference • Goals of weight loss and management (1-2 lbs/week) • Strategies for weight loss and management • Pharmacotherapy • Bariatric Surgery • Diet therapy (500 to 1000 kcal/d deficit) • Physical Activity (30 min moderate intensity most days)

  8. Time for an update • 2013 American Heart Association (AHA)/American College of Cardiology (ACC)/The Obese Society (TOS) Guideline for the Management of Overweight and Obesity in Adults • 2008 NHLBI initiated • June 2013 began collaboration with ACC/AHA • Other ACC/AHA 2013 guidelines • Assessment of cardiovascular (CV) risk • Lifestyle modifications to reduce CV risk • Blood cholesterol

  9. 2013 Overweight/Obesity Guidelines • Differ from other ACC/AHA guidelines • More limited in scope • Focus on select critical questions (CQ) based on the highest quality evidence available • Recommendations derived • Randomized trials • Meta-analyses • Observational studies evaluated for quality • Evidence not considered beyond 2011

  10. 2013 Overweight/Obesity Guidelines • Panel began with 23 possible CQ • Excluded CQ • Examples: genetics, binge, pharmacotherapy, cost effectiveness • Panel’s ultimate goal • Develop evidence statements (ES) and recommendations for 5 CQs to assist clinicians in primary care • Our goal today • Discuss summary of recommendations • Discuss 4 CQ and selected ES

  11. 2013 Overweight/Obesity Guidelines: CQ

  12. Critical Question 1 (CQ1) • Among overweight and obese (O/O) adults, does achievement of reduction in body weight with lifestyle and pharmacological interventions affect cardiovascular disease (CVD) risk factors, CVD events, morbidity and mortality? • Weight loss and risk of diabetes • Weight loss and impact on cholesterol/lipid profile • Weight loss and hypertension risk

  13. CQ1 (DM) • Weight loss and risk of diabetes (DM) ES: O/O adults at risk for T2DM • 2.5 to 5.5kg weight loss at > 2 years achieved w/ lifestyle intervention (+/- orlistat) reduced risk of developing T2DM by 30-60% ES: O/O adults withT2DM • 2 to 5% weight loss in 1-4 years (lifestyle +/- orlistat)lowered HgbA1c by 0.2-0.3% • 5-10% weight loss at 1 year (lifestyle +/- orlistat) associated with HgbA1c reductions of 0.6-1% and ↓ DM medications Strength of Evidence: High

  14. CQ1(DM)-mortality ES: O/O adults withT2DM • Intentional weight loss of 9 to13 kg had a 25% decrease in mortality rate vs. weight stable controls • Observational cohort studies Strength of Evidence: Low

  15. CQ1(lipid) • Weight loss and impact on lipid profiles ES: O/O adults +/- elevated CVD risk • Dose-response relationship between amount of weight loss (lifestyle) and the improvement in lipid profile • Weight loss • <3 kg: more modest/variable improvements in triglycerides (TG) , high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol • 3kg: decrease TG at least 15 mg/dL • 5 kg to 8 kg • Decrease LDL by ~5 mg/dL • Increase HDL by 2 to 3 mg/dL Strength of evidence: High

  16. CQ1(HTN) • Weight loss and hypertension (HTN) risk ES: O/O adults with +CVD risk (including T2DM/HTN) • Dose-response relationship between the amount of weight loss achieved at up to 3 years (lifestyle +/- orlistat) and the lowering of blood pressure (BP) • 5% weight loss: mean reduction observed • 3 mm Hg systolic BP • 2 mm Hg diastolic BP • <5% weight loss: more modest/variable BP reductions Strength of evidence: High

  17. Summary-CQ1 • Counsel O/O adults with CV risk factors that lifestyle changes that produce even modest, sustained weight loss of 3%-5% produce clinically meaningful health benefits • Greater weight losses = greater benefits • NHLBI grade: A (strong) • ACC/AHA: IA

  18. Critical Question 2 (CQ2) **Not enough evidence to answer

  19. NIH, NHLBI. Clinical Guidelines on the identification, evaluation, and treatment of overweight and obesity in Adults. The evidence report. NIH Publication No. 98-4083, 1998.

  20. Critical Question 2 (CQ2) • Associated with ↑ risk of combined fatal and nonfatal coronary heart disease (CHD) • Associated with ↑ risk of fatal CHD in both sexes • The current category for overweight • NOT associated with ↑ risk of all-cause mortality • BMI at or above the current cutpoint for obesity • ISassociated with an ↑ risk of all-cause mortality vs. normal weight ES: Current BMI cutpoint - O/O vs. normal ES: All-cause mortality Strength of Evidence: Moderate

  21. Summary-CQ2(Identify Patients who need to lose weight) • Calculate BMI at least annually • NHLBI grade: expert opinion • ACC/AHA: IC • Use current cutpoints: • For O/O to identify adults who may be at ↑risk of CVD • Obesity to identify adults who may be at ↑ risk of mortality from all causes • NHLBI grade: A (strong) • ACC/AHA: IB

  22. Summary CQ2(Identify Patients who need to lose weight) • Advise O/O adults that greater BMI= greater risk of CVD, T2DM, and all-cause mortality • NHLBI grade: A (strong) • ACC/AHA: IB • Measure waist circumference at annual visits or more frequently in O/O adults • Greater waist circumference= greater risk of CVD, T2DM, and all-cause mortality • NHLBI grade: expert opinion • ACC/AHA: IIB

  23. Critical Question 3 (CQ3)

  24. Summary: CQ3(Diets for weight loss) • Prescribe a diet to achieve reduced calorie intake for O/O individuals who would benefit from weight loss, as part of a comprehensive lifestyle intervention. • Prescribing options: NHLBI grade: A (strong)ACC/AHA: IB

  25. Summary: CQ3(Diets for weight loss) • Prescribe a calorie-restricted diet, for O/O individuals based on the patient’s preferences and health status and preferably refer to a nutrition professional for counseling • Variety of dietary approaches = weight loss • NHLBI grade: A (strong) • ACC/AHA: IB

  26. Critical Question 4 (CQ4)

  27. Critical Question 4 (CQ4) • ES: The principal components of an effective high-intensity, on-site CLIP include Strength of evidence: High

  28. Summary CQ4(lifestyle intervention and counseling) • Advise O/O individuals to participate for ≥6 months in a CLIP that assists participants in adhering to the principal components • NHLBI grade: A (strong) • ACC/AHA: IA • Prescribe on site, high-intensity CLIP in individual or group sessions by a trained interventionist (TI)† • NHLBI grade: A (strong) • ACC/AHA: IB † Trained internationalist (reviewed studies) included mostly health professionals (ie. RN, psychologist, exercise specialists, or health counselors).

  29. Summary CQ4(lifestyle intervention and counseling) • Electronically delivered weight loss programs (+ telephone) that include personalized feedback from TI can be prescribed but may result in smaller weight loss vs. face-to-face • NHLBI grade: B (moderate) • ACC/AHA: IIaA • Some commercial-based programs that provide a CLIP can be prescribed, provided there is peer-reviewed published evidence of safety and efficacy • NHLBI grade: B (moderate) • ACC/AHA: IIaA

  30. Summary CQ4(lifestyle intervention and counseling) • Use a very low calorie diet (defined as <800 kcal/day) • ONLY in limited circumstances • ONLY when provided by trained practitioners in a medical care setting • Medical supervision required (more discussion ahead) • NHLBI grade: A (strong) • ACC/AHA: IIA • Advise O/O individuals who have lost weight to participate long-term (≥1 year) in a CLIP • NHLBI grade: A (strong) • ACC/AHA: IA

  31. Summary CQ4(lifestyle intervention and counseling) • For weight loss MAINTENANCE • Prescribe face-to-face or programs that provide regular contact (> monthly) • With a trained interventionist who • Engage in high levels of physical activity • 200-300 minutes/week • Monitor body weight regularly • Weekly or more frequent • Consume a reduced-calorie diet (maintain lower body wt) • NHLBI grade: A (strong) • ACC/AHA: IA

  32. Comprehensive lifestyle + medically supervised programs • Veteran’s Administration • MOVE!(Managing Overweight and/or Obesity for Veterans Everywhere). • Evidence-based weight management program • Largest/most comprehensive weight management program • Individual, group, and activity sessions • MOVE! Intensive • Designed extreme obesity who have NOT been successful in MOVE!

  33. MOVE! Intensive • 12 day on-site program focus: diet, exercise and behavior • Criteria • BMI >35 w/ comorbid conditions or BMI >40 • Failure to achieve/maintain a 5-10% weight loss with standard MOVE! • Must be • Independent with all ADL’s • Able to walk 100 feet unassisted • Willing to complete health appraisal and sign behavioral agreement

  34. MOVE! Intensive • Team • Dietician • Nurse practitioner • Pharmacist • Physical therapist • Behavioral psychologist • Recreational therapist • Chaplain • Clearance by primary care provider (PCP) +/- • Mental health • Cardiac • Pulmonary • Hematology • GI/liver • Nephrology, etc

  35. MOVE! Intensive

  36. MOVE! Intensive

  37. MOVE! Intensive

  38. MOVE! Intensive • Discharge • 1200 calorie diet • Group or individual classes (dietician) • With most current medication adjustments • Follow-up within 2 weeks clinical pharmacist/PCP

  39. MOVE! Intensive • Data (8/2012-4/2014) • Average BMI: 42.41

  40. pharmacology Withdrawn… Still hanging on… • Fenfluramine(Pondimin,1973) • Dexfenfluramine (Redux, 1996) • Provider-initiated reports of valvular heart disease • Withdrawn September 1997 • Off-label use of “Fen-phen” • Sibutramine(Meridia,1997) • SCOUT trial: 16% ↑ in risk of major adverse CV events • Withdrawn: October 2010 • Diethylpropion HCL and ER (Tenuate, 1960) • Indication (C-IV) • Short-term adjunct (diet) for weight loss • Contraindications (CI) • Pulmonary HTN • Advanced arteriosclerosis • Hyperthyroidism • Glaucoma • Severe HTN • Agitated states • History drug abuse • MAOI within 14 days

  41. pharmacology Still hanging on… Still hanging on… • Orlistat (Alli, Xenical, 1999) • Indication • Weight loss AND maintenance with diet • Reduce the risk for weight regain after prior weight loss • CI • Pregnancy • Chronic malabsorption syndrome • Cholestasis • MVI indicated +/- 2hrs of dose • DI: levothyroxine (+/- 4hrs) cyclosporine (3hrs after) • Phentermine (Adipex-P, 1959) • Indication (C-IV) • Short-term adjunct (exercise/diet/behavior) for weight loss • CI • CVD (uncontrolled HTN, CVA, arrhythmias, CHF) • Hyperthyroidism • Glaucoma • Agitated states • History of drug abuse • MAOI within 14 days • Pregnancy/lactation • Drug interaction (DI) • SSRI: coadministration NOT recommended

  42. Pharmacology:the new kids on the block Phentermine/Topiramate (Qsymia) Locaserin (Belviq)

  43. Phentermine/Topiramate(Qsymia)The history... • 2008 reports: providers writing phentermine in am + topiramate bedtime • New Drug Application (NDA) 12/2009 phentermine/topiramate (Qnexa) • July 2010 reviewed by FDA committee • No efficacy issues cited • 2 safety concerns • Teratogenic potential • Detailed plan/strategy to evaluate and mitigate risk • Provide evidence that ↑heart rate (hr), 0.6 to 1.6 beats/min (bpm), does not increase the risk for major adverse cardiovascular events (MACE) • Results from SEQUEL

  44. Phentermine/Topiramate (Qsymia)The history... • SEQUEL • 1-year extension study to lookat a second year of exposure of obese subjects with obesity-related comorbidities • 676 subjects enrolled • Mean exposure: 728.5 days • Results • 1.6 bpm ↑hr (high dose) + 5.2 mmHg decrease in systolic BP (SBP) • Clinical relevance unknown (1−2 bpm increase in HR) • NO increase in MACE composite hazard ratios vs. placebo • Approved July 2012 • 10 postmarketing studies mandated • Potential name confusion

  45. Phentermine/Topiramate (Qsymia) • Indication (C-IV) • Adjunct (diet/exercise) for chronic weight management with BMI >30 or 27+ comorbidity • Dose titration • < 3% not achieved: ↑ dose • < 5% not achieved: d/c • CI • Pregnancy • MAOI within 14 days • Glaucoma • Hyperthyroidism • Caution/Consideration • Cardiac/CV disease • Not studied in HF • Excluded stroke/MI/unstable CV disease in previous 6 mo. • Elderly: >65 y.o. only 7% of subjects • On topiramate • Oral carbonic anhydrase inhibitor (avoid use) • CNS effects • Renal/hepatic impairment

  46. Phentermine/Topiramate (Qsymia) • Safety • The FDA-approved REMS program • Purpose • Increase awareness of congenital malformations • Prescriber Requirements • Encouraged to undergo the training • Counsel women of childbearing potential • Fax/mail universal form + prescription to certified pharmacy • Pharmacy Requirements • Certified to dispense • Staff must receive training • Medication guide + risk of birth defects brochure • Maintain a list of prescribers • Monitoring • BP, glucose, blood chemistry, mood

  47. Locaserin(Belviq)the history… • NDA December 2009 • 2 completed Phase III trials in non-diabetic (>7000 pts) • Phase III trial (BLOOM-DM) was ongoing • October 2010 FDA responded siting 4 main issues + updated safety (particularly valvulopathy) • Mammary tumor findings in female rats • Astrocytoma in male rats • Arequest to include data from BLOOM-DM • Assessment of abuse potential (2 rodent experiments)

  48. Locaserin (Belviq)the history… • April 2012 briefing document submitted to FDA • Mammary tumor • Pathology work group established tumor related to high dose (24x human exposure) • Astrocytoma • Extrapolated data: exposure in rat brain at dose level revealing NO astrocytoma was ~70x estimated level that 10mg bid would produce • Abuse potential • Repeated animal studies • Package insert • Human abuse potential study in recreational drug abusers, doses of lorcaserin (40 and 60 mg) • 2- to 6-fold increases on measures of “High”, “Good Drug Effects”, “Hallucinations” and “Sedation” vs. placebo • Similar to those produced by zolpidem and ketamine

  49. Locaserin (Belviq)the history… • Briefing (continued) • Safety update (valvulopathy) • Approved June 2012 • 6 postmarketing studies mandated

  50. Locaserin (Belviq) • Mechanism of action: serotonin 2C receptor agonist • Believed to decrease food consumption and promote satiety • Indication (C-IV) • Adjunct (diet/exercise) for chronic weight management with BMI >30 or 27+ comorbidity • Dose: 10 mg twice daily (max) • 5% of baseline body weight not lost by week 12 = discontinue

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